Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia

Inclusion Criteria:

• Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the AmericanDiabetes Association (ADA) Expert Committee on the Diagnosis and Classification ofDiabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit/Day 1

• HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit.

• High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg/L at the Screening Visit.

• Body mass index (BMI) ≥18 to ≤ 40 kg/m2 at the Screening Visit

• Acceptable overall medical condition to safely participate in the study and completeall study procedures (particularly with regard to cardiovascular, renal, and hepaticconditions), in the opinion of the Investigator

Exclusion Criteria:

• Diagnosis of type 1 diabetes mellitus

• HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit/Day 1, as determined at pointof care (local laboratory)

• Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulinanalogues (as bolus or premixed insulin) within 12 weeks prior to the ScreeningVisit

• Less than 80% compliance in taking investigational medicinal product by pill countduring the Run-In Period, as assessed at the Baseline Visit/Day 1

• Significant weight loss (> 5 kg) in the 12 weeks prior to the Screening Visit

• Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heartrate (HR) ≥ 100 beats/minute at the Screening Visit

• Previous myocardial infarction, any cardiac surgery